This is a Phase 1/2, open-label, dose escalation and dose expansion study designed to characterize the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of IBB0979 in previously treated patients with locally advanced or metastatic solid tumors.
Male or female, 18 to 80 years old.
With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors, either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate.
There is at least one assessable tumor lesion in the Dose Escalation Phase and at least one measurable lesion in the Dose Expansion Phase According to RECIST 1.1 (tumor lesions located in the previous radiation therapy area or other local regional treatment area generally not be considered as measurable lesions, unless the lesion has progression or persists after three months of radiation therapy).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.
Nitrosourea or mitomycin C should be within 6 weeks prior to the initiation of investigational product administration.
Oral fluoropyrimidines and small molecule targeted drugs should be within 2 weeks prior to the initiation of investigational product administration.
History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.
Sequential
IBB0979
DrugIBB0979 should be subcutaneous injected，qw
Frequency of adverse events (AEs) and SAEs (Phase Ⅰ)
To investigate the safety characteristics.
Dose limiting toxicities (DLTs) (Phase Ⅰ)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Objective response rate (ORR) in dose expansion (Phase Ⅱa)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1.
Pharmacokinetic (PK) Cmax (Phase Ⅰ)
PK parameters (Cmax) following single dose.following single dose.
Pharmacokinetic (PK) Cmin (Phase Ⅰ)
PK parameters (Cmin) following single dose.following single dose.
Pharmacokinetic (PK) Tmax (Phase Ⅰ)
PK parameters (Tmax) following single dose.
Pharmacokinetic (PK) AUC 0-t (Phase Ⅰ)
PK parameters (AUC 0-t) following single dose.
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